We are one company, Merck & Co., Inc., Kenilworth, New Jersey,
USA but we operate under two different corporate brand names.We are
Merck & Co., in the United States, Canada & Puerto Rico. We are
known as MSD outside the United States, Canada & Puerto Rico.
Associate Vice President, Regulatory CMC Diversified Brands
Franchise Lead - NR_Diversified BrandsCMC Lead_Aug 27 This job is
available in 2 locations Job Type Full time
Merck & Co. Inc. (headquartered in Kenilworth, NJ), has made the
decision to spin-off products from its Women’s Health, trusted
Legacy Brands, and Biosimilars businesses to form a new,
independent company. This new company, named “Organon”, will become
an independent, publicly traded company in 2021 with its global and
US headquarters to be based in Jersey City, NJ. We expect that
additional Organon sites will be in the general vicinity of current
For this exciting new opportunity, we are seeking candidates
with an entrepreneurial and learning spirit who are interested in a
career of purpose, personal growth and leadership. Working
together, we will make a significant impact on the health and lives
of people around the world.
For more information about Organon, please click here .
Reporting to the Head of Regulatory CMC, the Associate Vice
President (AVP) will provide regulatory leadership, oversight and
strategy to a team of Regulatory CMC Professionals in developing
global Regulatory CMC strategy and executing submissions for
products within the Diversified Brand portfolio. This large and
growing portfolio of pharmaceutical products for cardiovascular,
respiratory, dermatology and pain indications, including oral solid
dosage forms, sterile injectable and topical products. The AVP is
accountable for delivery of applicable CMC sections for life-cycle
maintenance submissions, post-approval changes, Agency Background
Packages, and responses to Agency questions for global markets for
existing products and Worldwide Marketing Applications for new
The AVP will drive alignment with partner organizations within
Manufacturing, Research and Development, and Commercial to assure
the optimal regulatory pathways are implemented to deliver on
business objectives and compliant supply. The AVP is accountable to
identify and communicate CMC regulatory risks and effectively
define mitigation strategies and regulatory plans in partnership
with senior leaders and stakeholders. The AVP will represent the
CMC organization in executive forums to drive overall strategy for
the Diversified Brands portfolio.
Critical to this role is the ability to lead a diverse global
team and to effectively attract, recruit and retain talent. The
individual leading this team, will need to demonstrate an ability
to navigate through complexity and flexibly allocate internal and
external resources to meet dynamic business priorities, while
keeping the team motivated, engaged and providing career
development opportunities. He/she will lead a team of approximately
40-50 permanent employees and external vendor resources to deliver
on corporate priorities.
Accountable for proactive and timely communication of regulatory
risks, challenges, and opportunities to management to help address
them in a systematic and thoughtful manner.
Develop, execute & provide oversight of regulatory initiatives &
strategies of significant complexity and apply exceptional
ingenuity to develop risk-based solutions to problems and mitigate
potential regulatory challenges.
Drive application of regulatory strategies and concepts across
multiple disciplines and multiple organizations, including working
directly with Executive Leadership in manufacturing, research and
development, commercial, and business development areas.
Embody the Organon Values and Leadership Behaviors in day-to-day
activities and serve as an example by practicing them
Actively coach team members to develop robust regulatory
strategies, embed risk management in ways of working and to develop
broad enterprise mindset.
Continuously evaluate and develop talent within the team and
prepare a succession plan.
Use recognition and rewards to promote team and organizational
Set a vision for the team and hold employees accountable for
execution of the organization’s policies and procedures.
Flexibly manage and allocate resources to support execution and
delivery of prioritized work to meet business commitments.
Cultivate and foster strong collaborative relationships with
stakeholders and partners across the organization.
Advocate for the CMC organization requirements and positions in
executive leadership forums.
Monitor the global regulatory environment to identify changes
with potential CMC impact and works closely with the Head of CMC to
implement updates to CMC strategic approaches, processes and
Develop and maintain expert knowledge of current global
regulatory CMC requirements for investigational submissions,
original registrations and post-approval changes. This includes
knowledge of the regulatory guidance for pharmaceutical and
combination products and the associated technologies.
Coach team to identify and resolve technical and operational
problems associated with regulatory strategy and submissions using
rapid, disciplined decision making and appropriate risk
Collaborate with peers to resolve cross-functional obstacles
using excellent critical thinking skills.
Influence innovative and scientifically sound approaches to gain
Participate in the development of CMC business processes or
organizational initiatives as needed.
Lead the Regulatory CMC discussions and interactions with
regulatory agencies to facilitate review and approval of
Develop and maintain an expert knowledge of Industry Association
Whitepapers, Health Authority regulations & guidance documents.
Utilize expert knowledge and reputation to influence the content of
new Industry Association Whitepapers, Health Authority guidance &
regulations. Present and participate at industry meetings.
Degree in Chemistry, Biology, Engineering, Pharmaceutical
Minimum 20 years pharmaceutical industry experience; 15 years
with an advanced degree.
Minimum 10 years working in Regulatory CMC, with progressive
experience in leading global programs across the product life
cycle, and minimum 10 years managing people.
The ideal candidate will have strong experience in Regulatory
CMC with strong technical leadership skills, as well as
demonstrated understanding of related pharmaceutical operations
(e.g., manufacturing, process development, analytical, and quality
assurance) and experience managing a team of Regulatory CMC
A candidate with strong experience in small molecule pre/post
approval expertise is highly preferred.
The candidate must demonstrate the ability to develop creative
and imaginative approaches to problem solving and the ability to
flexibly respond to changing priorities or unexpected events.
He/she must have a depth of experience in defining global
Regulatory CMC strategy, superb collaboration skills, rapid,
disciplined decision making and critical thinking capabilities, and
work well under pressure to be successful in this role.
The candidate must have excellent interpersonal, verbal and
written communication, presentation, and listening skills with a
proven record of working with, and influencing, multi-disciplinary
teams and external experts.
The candidate must have demonstrated experience in building,
rewarding and retaining key talent.
He/she must have proven experience in critically reviewing
detailed scientific information and assessing whether technical
arguments are presented clearly and conclusions are adequately
supported by data.
The candidate must be proficient in English; additional language
skills are a plus.
US and Puerto Rico Residents Only:
If you need an accommodation for the application process please
email us at email@example.com
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Employment Opportunity, visit:
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We are an equal opportunity employer,
Minority/Female/Disability/Veteran – proudly embracing diversity in
all of its manifestations.
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Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck
Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept
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Domestic/International VISA Sponsorship:
Yes Travel Requirements:
10% Flexible Work Arrangements:
Remote Work Shift:
1st - Day Valid Driving License:
No Hazardous Material(s):
Number of Openings:
Requisition ID: R72636
Email this job to: Organon will improve the lives of people
globally by unleashing the promise of trusted brands across women’s
health and other important therapeutic areas.
We are committed to becoming the world’s leading women’s health
company investing in innovations that support women’s
Invest in innovations to support women’s well-being, fueled by
our leading contraceptives and fertility business.
Establish a leading position in biosimilars, focusing on
oncology and inflammatory diseases, and being a partner in the
commercialization of biosimilars worldwide.
???????Realize the value of trusted dermatology, pain and
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other markets, please visit our MSD Careers page .
Information on this site is for the purpose of presenting career
opportunities at our organization and give our audience a view of
our culture, diversity and growth opportunities.
Our Company is an equal opportunity employer,
Minority/Female/Disability/Veteran, proudly embracing diversity in
all of its manifestations.